BioMark Technology

What is Metabolomics?

BioMark’s research and development is based on the science of metabolomics. Our studies focus on the pivotal role that metabolomics plays in early cancer detection with an aim to improve patient outcome.
Our research and technology development consist of:
  • Screening for the acetylated form of an FDA approved drug (called Amantadine) given to patients prior to measurement. This is done via LC MS in body fluids. This acetylation is performed by the enzyme called Spermine/Spermidine N-Acetyl Transferase (SSAT). It has been documented that elevated levels of SSAT are observed in many cancers including lung, breast, prostate, and GI cancers. Clinical trials on patients with cancer, as well as healthy subjects, provided proof of principle. In addition, studies in analysis of SSAT mRNA levels in tissue samples demonstrated elevated level of SSAT in various cancers. (See section under WHY)
  • Use of high performance metabolites for tissue specific cancers (see section under – CAN WE DETECT SPECIFIC TYPES OF CANCERS USING METABOLOMICS?)

BIOMARK DIAGNOSTICS’ CANCER DETECTION PLATFORM IS BASED ON METABOLOMICS

Why?

The enzyme is not the biomarker. The biomarker is the product (metabolite) of the enzymatic reaction. An over-expressed enzyme related to cancer will produce many thousands of times more metabolite, thereby exponentially increasing the signal-to-background-noise ratio. The result is an amplified biomarker that acts like beacon for early detection that no traditional biomarker can match.
BioMark has identified one such enzyme that is over-expressed in most types of cancer cells, therefore giving them the ability to detect many tumors. This enzyme is called spermidine/spermine acetyltransferase (SSAT) and it converts an FDA-approved drug called amantadine into an acetylated form called N-acetylamantadine. N-acetylamantadine is produced in high amounts in cancer cells and is easily detected in urine in a cost-effective manner.

Current cancer detection assays are limited

Most non-imaging cancer detection assays available today are validated to detect biomarkers that are over-expressed in cancer cells. A majority of these biomarkers are proteins that have become mutated in cell-signaling pathways or highly expressed on the surface of cancer cells. This approach is powerful, but has its limitations when it comes to detecting cancer at the early stages.

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BioMark’s assay can become the front line in cancer detection. During physical examinations, a patient will take a FDA Approved and safe pill (amantadine) that acts as a smart drug, and after 2-4 hours, submits a urine sample for analysis. If the levels of N-acetylamantadine in the urine are elevated above normal levels, traditional methods are then incorporated to specify the location of the cancer. This approach will save the medical system billions of dollars annually and prevent unnecessary harm to patients caused by otherwise invasive procedures.

Can we detect specific types of cancers using metabolomics?

BioMark Diagnostics has developed new high powered metabolic signatures to increase tumour specificity for lung with Dr. Wishart’s TMIC group at University of Alberta. The TMIC group along with BioMark are conducting a large retrospective lung cancer study using its customized assay.

Our current focus: Lung cancer

BioMark Diagnostics is currently performing the following studies in the detection and risk assessment of patients with lung cancer:

  • BioMark is in the process of completing a phase III trial consisting of over 250 patients in Canada and Bangladesh with emphasis on lung cancer.
  • Measuring early response to chemotherapy treatment for lung cancer patients at CancerCare Manitoba under Dr. Andrew Maksymuik.
  • Measuring patient response to treatment following lung cancer resection using our signature metabolites. A high-level protocol has been completed and submission to an Ethics Board is planned. The trail will include about 100 to 130 subjects and the principal investigator will be Dr. James Bond.
  • Increasing our lung cancer samples from 100 patients to about 300 patients for TMIC assay optimization through a collaborative multiple party study involving CancerCare Manitoba, Saint Boniface Research Centre and TMIC
  • In a proposed trial, we will aim to identify high-risk patients associated with smoking – proposed trial with Dr. Samantha Kimball and perhaps an oncologist from Alberta. Using our technology to increase the uptake of CT scans for individuals at high risk of lung cancer, and also to monitor false negatives after CT scans and biopsy.
  • Building analytics component leveraging IBM’s Bluemix big data platform that can improve predictability of the assay.

We strongly believe BioMark’s technology can be disruptive to the diagnostics industry and potentially become an integral frontline defense in early cancer detection, measuring response to treatment and monitoring for early recurrence.